Collection device and material

ABSTRACT

Swabs, and materials of the present disclosure, and methods of making same, include randomly arranged sea-island bicomponent fibers.

The present application claims benefit of U.S. Provisional ApplicationNo. 61/326,466, filed Apr. 21, 2010, the entire contents of which isincorporated herein by reference.

TECHNICAL FIELD

The present disclosure describes a swab, and collection material for usetherein, for collecting biological specimens.

BACKGROUND

Devices, such as swabs, for collecting biological specimens of organicmaterial are known in the field of clinical and diagnostic analyses,which generally include a cylindrical rod or stick containing on acollection end or tip a wad of fiber material, such as rayon or anatural fiber such as cotton, with hydrophilic properties to allow rapidabsorption of the quantity of specimen to be collected and tested.Stable adherence of the fiber wrapped around the end or tip of the rodor stick is generally achieved by gluing.

Collection swabs containing the collected material are often immersed ina culture media, such as in a test tube, vial, culture dish, or culturebottle, soon or immediately after collection to preserve and conservethe collected specimen during storage and/or transport to, for example,an analytical laboratory. Collection swabs and devices of the prior artare described, for example, in EP0643131 and WO2004/086979.

SUMMARY

Devices, such as swabs, and materials of the present disclosure, andmethods of making same, include randomly arranged sea-island bicomponentfibers.

The present disclosure provides a swab for collecting and releasing abiological sample containing an applicator and sea-island bicomponentfibers,

The swab of present disclosure contain fibers attached to an end portionof the applicator, such as by adhesive.

The present disclosure provides a method of forming the swab of thedisclosure which includes adhering the bicomponent fibers to theapplicator.

The present disclosure provides a method of collecting a biologicalsample which includes contacting the swab of the disclosure with asource of biological material such that a sample of the material isretained by the swab.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 provides an end view of a bicomponent fiber of PET/PET.

FIG. 2 is a photograph of an experimental swab stick head.

DETAILED DESCRIPTION

Devices, such as swabs, and materials of the present disclosure, andmethods of making same, include randomly arranged sea-island bicomponentfibers.

Materials of the present disclosure may be included as a high absorbencymember of medical swab devices. The “splitable” flock fiber materials ofthe present disclosure attached to the end of a thin “stick-like”polymeric shaft are described and contemplated herein as swabs of thepresent disclosure.

The materials of the disclosure may include micro- and nano-fibers, suchas bicomponent sea-island materials. Segmented pie materials may also beused. Bicomponent sea-island materials and segmented pie materials areknown and described, for example in Ndaro et al Journal of EngineeredFibers and Fabrics, volume 2, Issue 4, 2007 “Splitting ofIslands-in-the-Sea Fibers (PA6/COPET) During Hydroentanging ofNonwovens”; and Fedorova, Nataliya “Investigation of the Utility ofIslands-in-the-sea Bicomponent Fiber Technology in the SpunBond Process”Ph.D. Dissertation, North Carolina State University, Raleigh, N.C.(2006); as well as in U.S. Patent Application Publication Nos.:20100075143 (FIBER STRUCTURE AND METHOD FOR PRODUCTION THEREOF),20100068516 (THERMOPLASTIC FIBER WITH EXCELLENT DURABILITY AND FABRICCOMPRISING THE SAME), and 20100029158 (ISLANDS-IN-SEA TYPE COMPOSITEFIBER AND PROCESS FOR PRODUCING SAME), And WO2002042528 (A SEA-ISLANDTYPED COMPOSITE FIBER USED IN WARP KNITTING, AND A PROCESS OF PREPARINGFOR THE SAME), WO2002042529 A SEA-ISLAND TYPE COMPOSITE FIBER FOR RAISEDWARP KNIT FABRIC, AND A PROCESS OF PREPARING FOR THE SAME), WO2002088438(A SEA-ISLAND TYPED CONJUGATE MULTI FILAMENT COMPRISING DOPE DYEINGCOMPONENT, AND A PROCESS OF PREPARING FOR THE SAME), and as arecommercially available from, for example, Kolon Industry, Kumi City,Kyungbuk, Korea and generally described as ROJEL—polyester/polyesterconjugated fiber yarn (sea/island) or SPECIAL TYPE OFROJEL—polyester/nylon conjugated fiber yarn (sea/island); or HyosungCorporation, Ulsan City, Kyungbuk, Korea and generally described asMIPAN XF-Nylon/polyester conjugated yarn (pie-wedge cross-section).

In the islands-in-sea type composite fiber of the presently describedmaterial, an easily soluble polymer is incorporated for the sea portionand preferably contains at least one polymer easily soluble in aqueousalkali solutions, such as polylactic acid, super high molecular weightpolyalkyleneoxide-condensate polymers, polyethyleneglycolcompound-copolymerized polyesters, and copolymerized polyesters ofpolyethylene glycol (PAG) compounds with 5-sodium sulfoisophthalic acidor dimethyl-5-sulfoisophthalate sodium salt (DMIS). Polyester seamaterials may include alkali soluble copolymer polyester materials withpolyester mainly containing polyethylene terephthalate of more than 90mole percent as island component (such as is described, for example, inWO2002042528, the entire contents of which is incorporated herein byreference).

The islands-in-sea type bicomponent composite fiber of the presentdisclosure contains a sea part containing or composed of polymer ofgreater solubility than a plurality of island parts containing orcomposed of a less soluble polymer, in the cross-sectional profile ofwhich the number of the island parts is about 10, 24, 36, 37, 64 or 240islands per fiber, or ranges of islands per fiber between any of 10, 24,36, 37, 64, 240 or 3000 islands per fiber.

The island component of the bicomponent composite fiber of the presentdisclosure may be a polyamide, such as nylon, or a polyester. Examplesof the polyamide include polymers having an amide bond, such as nylon 6,nylon 66, nylon 610, and nylon 12. The polyester is not particularlylimited as long as it is a polymer synthesized from dicarboxylic acid oran ester-forming derivative and diol or an ester-forming derivativethereof and can be used as the fiber. Specific examples thereof includepolyethylene terephthalate, polytrimethylene terephthalate,polytetramethylene terephthalate, polycyclohexylenedimethyleneterephthalate, polyethylene-2,6-naphthalene dicarboxylate,polyethylene-1,2-bis(2-chlorophenoxy)ethane-4,4′-dicarboxylate and thelike. In an embodiment of the present invention, a polyethyleneterephthalate or a polyester copolymer containing mainly an ethyleneterephthalate unit, may be used.

The islands-in-sea type bicomponent composite fiber of the presentdisclosure have a linear mass density in the range of about 1-7 deniers,alternatively in the range of about 2 to 6 deniers or the range of 2 to5.8 deniers (or 2.22 to 6.49 dtex) wherein a denier is the mass in gramsper 9000 meters of fiber and dtex is the mass in grams per 10,000meters. The diameter (0, in centimeters) of a bicomponent compositefiber may be estimated from the following formula, wherein ρ representsa materials density in grams per cubic centimeter:

$\varnothing = \sqrt{\frac{4 \times {10^{- 6} \cdot {dtex}}}{\pi \; \rho}}$

Estimating the fiber specific gravity as being equal to 1 (specificgravity values of common fiber polymers according to Gafe et al(“Polymeric Nanofibers and Nanofiber Webs: A New Class of Nonwovens”INTC 2002: International Nonwovens Technical Conference (JointINDA—TAPPI Conference), Atlanta, Ga., Sep. 24-26, 2002) are as follows:0.92 (polypropylene or PP), 1.14 (polyamide 66 or nylon or PA66) and1.38 (polyethylene terephthalate or PET)), the diameter of bicomponentcomposite fiber of the present disclosure having a linear mass densityin the range of 2 to 5.8 deniers would be about 16.7 μm to 28.6 μm.

The islands of the bicomponent composite fibers of the presentdisclosure have a mass linear density of about 0.01 to about 0.3deniers, or about 0.05 to about 0.2 deniers, or about 0.06 to about 0.16deniers, depending on the linear mass density of the bicomponentcomposite fibers of the present disclosure.

The islands-in-sea type bicomponent composite fibers of the material ofthe present disclosure have a length, or cut length, of about 10 toabout 100 thousandths of an inch (about 254 μm to about 2,540 μm), orabout 20 to about 90 thousandths of an inch, or about 20 to about 80thousandths of an inch, or about 20 to about 70 thousandths of an inch,or about 20 to about 60 thousandths of an inch.

The islands-in-sea type bicomponent composite fibers of the material ofthe swabs of the present disclosure are not split. The seas of theislands-in-sea type bicomponent composite fibers of the material of theswabs of the present disclosure are not dissolved or removed from theislands of the composite fibers.

FIG. 1 is a scanning photograph of an example of a fiber of the presentdisclosure wherein ends of the bicomponent composite fibers isillustrated and the islands of the fiber is intact and not dissolved orremoved.

The bicomponent composite fibers of the material of the presentdisclosure are preferably randomly arranged.

The number of fibers on a swab of the present disclosure may beevaluated by light microscope (Amscope) at 180× power with a 1 mmcalibration scale (NIST) in conjunction with a video camera (Amscope 3.0megapixel) and suitable video analysis software, such as for example,Version 3.0.12.498 Amscope video software calibrated to 180×.

A swab of the present disclosure, which includes material of the presentdisclosure, may be any shape adapted for collection, and optionalretention, of biological samples from a host directly or alreadycollected biological fluid or sample. Shapes and sizes of such devicesare known in the art. The swab of the present disclosure is constructedof materials known in the art, such as acrylonitrile-butadiene-styrene(ABS). The swab of the present disclosure is such that the material ofthe present disclosure may be attached to the applicator of the swabthrough an adhesive during a flocking technique known in the art.

An applicator of the swab of the present disclosure may be a rod orrod-like thermoplastic substrate wherein one end is coated, partially,substantially or completely, with an adhesive to anchor or hold fibersof the present disclosure to the substrate in an initial arrangementgenerally perpendicular to the substrate and generally parallel toadjacent fibers to thereby create, for example, a bristle or bristly endon the substrate.

In a method of making devices according to the present disclosure,individual, loose or connected substrate, such as applicator shafts,sticks or rods have adhesive applied by at least one adhesive applicatorcontainer, block, head, nozzle, or roller by, for example, spraying,dipping, rolling, printing or a combination thereof, optionally in ametered fashion, under pressure or by gravity, and in a manner which mayor may not include any combination of linear and/or rotational, such asby axial rotation or spinning, of the adhesive applicator relative tothe applicator.

In the flocking technique of the present disclosure, an electric fieldof alternating or direct current is applied to the fibers in a mannerknow in the art to organize and transport charged fibers to oppositecharged adhesive-covered substrate such that the fibers are held inplace by the tackiness or adhesive strength of the adhesive, only inareas where the adhesive has been applied to produce flock fiber tippedapplicators, or swabs of the disclosure. The technique may includemovement of the substrate, linearly and/or rotationally, such as byaxial rotation or spinning, at any time or throughout the process ofapplying fibers to the adhesive. Where further curing of the adhesive,such as by light or heat, is required, the flock fiber tipped applicatorswab may be treated with light and/or heat so as to cure the adhesive.

Swabs of the disclosure may contain approximately 10⁴ to approximately10¹⁰, or approximately 10⁴ to approximately 10⁹, or approximately 10⁴ toapproximately 10⁸, or approximately 10⁴ to approximately 10⁷, orapproximately 10⁴ to approximately 10⁶, or approximately 10⁴ toapproximately 10⁵, flock fibers per substrate.

The adhesive of the present disclosure is not particularly limited andgeneral and photo or heat cured acrylic-based, polyurethane-based,polyamide-based, polyester-based, vinyl-based and/or two-part epoxyadhesives may be used. Silicones, cyanoacrylates, polyurethanes and/orlatex adhesives may be used. Polyurethane adhesive are generally knownand available, such as from K&W Adhesive Products.

The swabs of the present disclosure are adapted or designed forcollection of, for example, biological samples from oral, nasal, ocular,rectal, urethral, or vaginal orifices of a mammal, such as a human, orpatient.

The swabs may be used and is designed for collection of a biologicalspecimen by contact with the fibers of the device such that the devicemay collect, for example, about 35 to about 200 μl, such as 40, 50, 60,70, 80, 90, 100, 120, 130, 140, 150, 160, 170, 180 or 190 μl, withoutcausing damage or substantial discomfort to the patient during specimencollection.

The swabs of the present disclosure is useful for and in a method ofcollecting biological specimens. A swab of the present disclosure is ofthe type containing a rod terminating with a tip covered in the fibersdescribed herein to allow absorption of said specimens, wherein thefibers cover or substantially cover the tip in the form of a layerapplied by means of flocking.

The present disclosure further provides a method of collecting abiological sample which includes contacting a swab as described hereinwith a source of biological material such that a sample of the materialis retained by the swab.

The swabs of the disclosure may be provided, for example, as a componentpart of a collection, transport, culture and/or transport kit or devicewherein additional specimen handling containers and/or devices areincluded and the swab of the present disclosure is specially adapted tobe integrated with such other container and/or devices to assure, forexample, specimen retention, integrity and/or sterility.

The present disclosure provides a swab for collecting and releasing abiological sample containing sea-island bicomponent fibers. The swabsmay further contain bicomponent fibers which are composed of a firstpolyester sea material and a second polyester island material; the firstpolyester may have a lower melting point than the second polyesterand/or the first polyester may have a greater solubility in alkalinesolution than the second polyester. The alkaline solution may morespecifically be a sodium hydroxide solution—the sodium hydroxidesolution may contain about 5% to about 50% by weight sodium hydroxide inwater, or alternatively about 10% by weight sodium hydroxide in water.The alkaline solution wherein the first polyester sea material is moresoluble than the second polyester sea material may be a heated alkalinesolution—the heated alkaline solution alternatively having a temperatureof about 170° F. to about 190° F., such as about 180° F.

The present disclosure provides a swab, wherein material describedherein is attached to an end portion of an applicator stick or rod. Thematerial may be adhered to the end of the applicator with an adhesive,and the adhesive may be a photocurable acrylic adhesive or apolyurethane adhesive.

The bicomponent fibers of the present disclosure may be composed of apolyethylene terephthalate sea material and a polyamide island material.

The bicomponent fibers of the present disclosure may be composed of orcontain 10-3000 island parts per fiber, 10-240 island parts per fiber,10-64 island parts per fiber, 10-37 island parts per fiber, 10-36 islandparts per fiber, 10-24 island parts per fiber, and/or 24-36 island partsper fiber.

The present disclosure provides the fibrous material of the swabdescribed herein. The fibrous material may be incorporated separately asa part of a device other than a swab, such as a filter or cleaning pador brush.

The present disclosure provides a method of forming a swab of thedisclosure involving adhering the bicomponent fibers to an applicator,such as a rod or stick, wherein the sea component of the fiber is notremoved.

The following examples further illustrate the materials and methods ofthe disclosure without limiting same.

Example 1 SWABS

A quantity of (about 30 or so) experimental medical swabs were preparedfrom ABS plastic “sticks” of Puritan Medical Products (Guilford, Me.)with 0.5 mm long (0.020″, nominal length, as determined by aFlock-In-Spect flock fiber length optical measurement instrument)Nylon/PET sea/island type flock fiber. Two adhesive systems wereemployed in these experimental fabrications; the polyurethane rubber(K&W polyurethane adhesive—MECFLOCK L876/1, MEDCODUR H5530 two partpolyurethane adhesive, mixed 85 grams L876/1 resin and 15 grams H5530hardener—product of Kissel and Wolf; cured 3 hours at 110° C. or elsecured 16 hours at 80° C.). and a UV photo-curable adhesive from PuritanMedical Products.

The following materials and instruments were used in fabrication: ABS(plastic) swab sticks (supplied by Puritan); Maag Flockmaschinen Motion(flock activity) Tester SPG 1000; K & W adhesive in a shallow aluminumdish (adhesive depth about 1 cm); photo-curable adhesive inlight-blocked packet; flock screen sifter; and a supply of Nylon/PET 0.5mm long Flock fibers

The experimental swabs were fabricated as follows. The flock activitytester's 4″ diameter aluminum base plate is covered (by sifting) withabout 2 grams of loose flock. This sample of loose flock was mounted onto the bottom electrode pedestal of the Flock Activity Tester. The endof the swab sticks were perpendicularly dipped into the fluid K & Wadhesive to a depth of about 1 cm and slowly removed to produceend-coated swab-sticks. Some swab samples were made using photo-curableadhesive. Water-based acrylic (F1059B Lubrizol Corp.) flock adhesive andother water based adhesives could be used. A 3.5 KV/cm strength wasapplied to the DC electrodes of the Flock Activity Tester (upflockingmachine). This causes the flock fibers to align themselves and activelymove to the top electrode. As this flock is being propelled from thebottom to the top electrode, the adhesive coated tip plastic swab-stickis then placed in the “flock fiber cloud” about 1 cm from the bottomelectrode (source of the activated flock fibers). While in the “flockfiber cloud”, the swab-stick was slowly rotated by rolling the stickheld in gripping fingers.

Flock fibers fully adhered to the saturate at the (adhesive wet) end ofthe swab-stick after about a 2 to 5 second flock field immersion time.The swab adhesive was subsequently cured.

The average amount of adhesive and the average amount of flock appliedto the ABS base (sticks) were determined by weight with the followingresults: average weight of “Bare” ABS sticks: 0.5644+/−0.00426 grams;average weight of K & W Adhesive on “Sticks” before flocking: 0.0046grams; and average weight of PET/Nylon Flock on “Sticks”: 0.0135 grams.With an average of 0.0135 grams of sea/island flock fiber on each“stick” this translates to approximately 1.2×10⁵ flock fibers per“stick”.

The water “pick-up” capabilities of the flocked medical swabs wasdetermined by a procedure whereby a number of swab and “stick” materialswere first weighed (dry). Then this same series of flocked swabs and“sticks” were immersed in room temperature (23° C.) water (tips only)for 5 seconds and then reweighed.

The percent water pick-ups of the various swab configurations were thencompared. The results demonstrate that the “bare” ABS swab stickspick-up or capture little or no water. The polyurethane adhesive coated(tip only) swabs picked up or captures a little water indicating thatthe adhesive is a more wettable surface that the “bare” ABS. The flockedfiber swab picked up or captured a measurable amount of water (8.95%).

Several fiber material types (of sea/island fiber) have been evaluated.The nylon/PET (Kolon) and PET/PET (Kolon-Rojel) fibers appear useful inthe fiber flocked medical swab application of the present disclosure.While 0.5 mm long nylon/PET flock fiber were initially investigated,fibers of various sizes may be used and are contemplated.

The following two flock adhesives have been investigated: thetwo-package polyurethane (clear rubbery) and the photo-curable (clearfilm plastic) systems. Other adhesives are contemplated.

All literature and publications referred to and described herein areincorporated herein in their entirety.

1. A swab for collecting and releasing a biological sample comprising anapplicator and sea-island bicomponent fibers.
 2. The swab of claim 1wherein said bicomponent fibers comprise a first polyester sea materialand a second polyester island material.
 3. The swab of claim 2 whereinsaid first polyester has a lower melting point than said secondpolyester.
 4. The swab of claim 2 wherein said first polyester has agreater solubility in alkaline solution than said second polyester. 5.The swab of claim 4 wherein the first polyester has a greater solubilityin alkaline solution of sodium hydroxide, as compared to the secondpolyester.
 6. The swab of claim 5 wherein the first polyester hasgreater solubility in an alkaline solution of sodium hydroxide solutioncontaining about 5% to about 50% by weight sodium hydroxide in water, ascompared to the second polyester.
 7. The swab of claim 6 wherein thefirst polyester has greater solubility in an alkaline solution of about10% by weight sodium hydroxide in water, as compared to the secondpolyester.
 8. The swab of claim 4 wherein the first polyester hasgreater solubility in a heated alkaline solution as compared to thesecond polyester.
 9. The swab of claim 8 wherein the first polyester hasgreater solubility in an alkaline solution heated to a temperature ofabout 170° F. to about 190° F. as compared to the second polyester. 10.The swab of claim 1 wherein the fibers are attached to an end portion ofsaid applicator.
 11. The swab of claim 10 wherein said fibers areadhered to said end portion with an adhesive.
 12. The swab of claim 11wherein said adhesive is selected from the group consisting of aphotocurable acrylic adhesive and a polyurethane adhesive.
 13. The swabof claim 1 wherein said bicomponent fibers comprise a polyethyleneterephthalate sea material and a polyamide island material.
 14. The swabof claim 1 wherein said bicomponent fibers comprise 10-3000 island partsper fiber.
 15. The swab of claim 14 wherein said fibers comprise 10-240island parts per fiber.
 16. The swab of claim 14 wherein aid fiberscomprise 10-64 island parts per fiber.
 17. The swab of claim 14 whereinaid fibers comprise 10-37 island parts per fiber.
 18. The swab of claim14 wherein aid fibers comprise 10-36 island parts per fiber.
 19. Theswab of claim 14 wherein aid fibers comprise 10-24 island parts perfiber.
 20. The swab of claim 14 wherein aid fibers comprise 24-36 islandparts per fiber.
 21. A method of forming the swab of claim 10 comprisingadhering the bicomponent fibers to said applicator.
 22. A method ofcollecting a biological sample comprising contacting the swab of claim 1with a source of biological material such that a sample of the materialis retained by the swab.